Physical Activity in Patients With Systemic Lupus Erythematosus

NCT06919250 | Not Yet Recruiting

• 1 other identifier: ActLup
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Background. Systemic lupus erythematosus is a chronic autoimmune disease. Among its main clinical manifestations are musculoskeletal symptoms such as myopathies, arthritis, arthralgias or osteonecrosis. Physical activity can improve the perception of quality of life and well-being of these patients. Objective. To assess the degree of physical activity in patients with systemic lupus erythematosus, and to identify the main clinical, sociodemographic and anthropometric variables that influence it. Method. Ambispective cohort study. Sixty-three patients with systemic lupus erythematosus will be recruited. The primary variable will be the degree of physical activity (International Physical Activity Questionnaire). Secondary and modifying variables will be: fatigue (Fatigue Assessment Scale), health-related quality of life (Short Form-36 Health Survey), sleep disorders (Pittsburgh Sleep Quality Index), depressive (Beck Depression Inventory -II) and anxiety symptoms (Hamilton Anxiety Rating Scale), age, and disease activity, duration and damage. Possible confounding variables will be sex, toxic habits (smoking), diagnosis of other pathologies and exposure to therapy. In the analysis, the degree of physical activity of patients with lupus erythematosus will be calculated and a multiple regression analysis will be performed to evaluate the predictive model that best fits the degree of activity of these patients. Expectedresults. To identify the degree of physical activity of patients with systemic lupus erythematosus and to identify the predictive model of physical activity in these patients.

Conditions

Lupus Erythematosus, Systemic

Keywords

Systemic Lupus Erythematosus; Physical activity; Prevention; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Measurement of the degree of physical activity

  The degree of physical activity will be assessed with the International Physical Activity Questionnaire (IPAQ). This tool assesses the time spent walking and sitting. The results are classified into three categories: low, moderate and high activity. The unit of measurement is the units of measurement of the metabolic rate (METS), where the higher the number of METS, the greater the physical activity.

  Screening visit

Secondary Outcomes (9)

• Measurement of health-related quality of life

  Screening visit

• Measurement of fatigue

  Screening visit

• Measurement of sleep disorders

  Screening visit

• Measurement of depressive symptoms

  Screening visit

• Measurement of anxiety symptoms

  Screening visit

Other Outcomes (4)

• Measurement of gender

  Screening visit

• Measurement of toxic habits

  Screening visit

• Assessment of the diagnosis of other pathologies with a questionnaire

  Screening visit

Study Arms (1)

Patients with systemic lupus erythematosus

Patients with systemic lupus erythematosus who will participate through an interview format with closed questions where no data will be collected that would allow identification of the subjects.

Other: Patients with systemic lupus erythematosus

Interventions

Patients with systemic lupus erythematosus OTHER

Population: Patients with systemic lupus erythematosus. Intervention: Identification of the degree of physical activity of patients with systemic lupus erythematosus.

Patients with systemic lupus erythematosus

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with systemic lupus erythematosus

You may qualify if:

• Patients with a diagnosis of systemic lupus erythematosus
• Of legal age
• Residents in Spain
• Who sign the informed consent document.

You may not qualify if:

• Patients dependent in the development of activities of daily living.
• Unable to ambulate without the help of third parties.
• Who have undergone surgery in the last 6 months.

Sponsors & Collaborators

• University of Oviedo: lead

Study Sites (1)

University of Oviedo

Oviedo, Principality of Asturias, 33006, Spain

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Motor Activity

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Rubén Cuesta-Barriuso, PhD

  Universidad de Oviedo

  STUDY DIRECTOR

Central Study Contacts

Rubén Cuesta-Barriuso, PhD

CONTACT

607547274; cuestaruben@uniovi.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 9, 2025
• Study Start: March 31, 2025
• Primary Completion: April 28, 2025
• Study Completion: May 20, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-03

Locations

ES (1)